Devices and methods for transferring fluid to or from a vial

• US 9,662,272 B2
• Filed: 01/29/2015
• Issued: 05/30/2017
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Warren, Dee E., Lopez, Dan
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US14/608,754
• Publication Number:
  US 20150136271A1
• Time in Patent Office: 852 Days
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2079 Filtering means
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61J 2200/76 for fluid level
• CPC Class Codes: Y10T 137/0402 Cleaning, repairing, or assembling
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

In certain embodiments, a vial adaptor for removing liquid contents from a vial comprises a housing and a bag. In some embodiments, an initial volume of a regulating fluid can be contained within the bag. In some embodiments, the regulating fluid flows into the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial. In some embodiments, a vial adaptor is coupled with the vial in order to remove the liquid. In some embodiments, as the liquid is removed from the vial via the adaptor, the bag expands, and in other embodiments, the bag contracts.

Claims

1. A vial access device configured to aid in accessing contents of a vial containing a volume of a medical fluid, the device comprising:

a piercing member configured to pierce a septum of the vial;

a distal extractor aperture on the piercing member configured to permit withdrawal of the medical fluid from the vial when the device is coupled to the vial, wherein the distal extractor aperture leads to an extractor channel that is placed in fluid communication with an interior of the vial when the device is coupled to the vial;

a distal regulator aperture configured to permit fluid communication between the vial and the device when the device is coupled to the vial, wherein the distal regulator aperture leads to a regulator channel that is placed in fluid communication with the interior of the vial when the device is coupled to the vial;

a medical connector interface in fluid communication with the extractor channel, wherein the medical connector interface is configured to interface with a syringe that has no exposed needle; and

a reservoir in fluid communication with the regulator channel, the reservoir containing an initial volume of a regulating fluid, the reservoir configured to contract when the medical fluid is withdrawn from the vial via the extractor channel,

wherein the reservoir is configured to supply at least some of the initial volume of regulating fluid to the vial via the regulator channel, thereby facilitating withdrawal of the medical fluid from the vial and compensating for such withdrawal of the medical fluid from the vial.

2. The device of claim 1, wherein the reservoir is outside of the vial.

3. The device of claim 1, wherein the reservoir is within a housing member.

4. The device of claim 3, wherein the housing member comprises a plurality of components attached in substantially airtight engagement.

5. The device of claim 1, wherein the reservoir comprises a balloon.

6. The device of claim 1, wherein the initial volume of regulating fluid comprises sterilized air.

7. The device of claim 1, further comprising a filter in communication with the regulator channel.

8. The device of claim 7, wherein the filter is hydrophobic.

9. The device of claim 1, wherein the initial volume of regulation fluid is equal to or greater than the volume of medical fluid contained in the vial.

10. The device of claim 1, wherein the pressure within the vial does not significantly increase as fluid is removed from the vial.

11. The device of claim 1, wherein the reservoir comprises a canister made out of a resilient material.

12. The device of claim 11, wherein the reservoir comprises polypropylene.

13. The device of claim 1, wherein the reservoir comprises silicone rubber.

14. The device of claim 1, wherein the reservoir comprises polyisoprene.

15. The device of claim 1, wherein the reservoir comprises a material that is substantially impervious to liquid and air.

16. The device of claim 1, wherein the reservoir is circularly symmetric about a longitudinal axis passing through a center of the reservoir.

17. A method of manufacturing a device configured to couple with a vial containing a medical fluid, the method comprising:

forming a housing member, the housing member including a distal extractor aperture configured to permit withdrawal of the medical fluid from the vial when the device is coupled to the vial, wherein at least a portion of an extractor channel and at least a portion of a regulator channel pass through the housing member; and

placing a reservoir in fluid communication with the regulator channel, the reservoir containing an initial volume of a regulating fluid, the reservoir configured to contract when the medical fluid is withdrawn from the vial via the extractor channel,

wherein the housing member includes at least one piercing member having a distal regulator aperture leading to the regulator channel,

wherein the at least one piercing member is configured to pierce a septum of the vial and thereby be placed in fluid communication with an interior of the vial when the device is coupled with the vial;

wherein the reservoir is configured to supply at least some of the initial volume of regulating fluid to the vial via the regulator channel, thereby facilitating withdrawal of the medical fluid from the vial and compensating for such withdrawal of the medical fluid from the vial; and

wherein the extractor channel is in fluid communication with a medical connector interface configured to interface with a syringe that has no exposed needle.

18. The method of claim 17, further comprising inserting sterilized air into the reservoir, the sterilized air being the regulating fluid.

19. The method of claim 18, wherein the initial volume of regulation fluid is equal to or greater than the volume of medical fluid contained in the vial.

20. A vial access system configured to aid in accessing contents of a vial containing a volume of a medical fluid, the system comprising:

a piercing member configured to pierce a septum of the vial;

a distal extractor aperture on the piercing member configured to permit withdrawal of the medical fluid from the vial as a result of the system being coupled to the vial, wherein the distal extractor aperture leads to an extractor channel that is configured to be placed in fluid communication with an interior of the vial as a result of the system being coupled to the vial;

a distal regulator aperture configured to permit fluid communication between the vial and the system as a result of the system being coupled to the vial, wherein the distal regulator aperture leads to a regulator channel that is configured to be placed in fluid communication with the interior of the vial as a result of the system being coupled to the vial; and

a reservoir in fluid communication with the regulator channel, the reservoir containing an initial volume of a regulating fluid, the reservoir configured to decrease in volume as a result of the medical fluid being withdrawn from the vial via the extractor channel;

wherein the initial volume of regulating fluid comprises sterilized gas configured to remain sterile up through coupling the system with the vial; and

wherein the reservoir is configured to supply at least some of the initial volume of regulating fluid to the vial via the regulator channel, thereby facilitating withdrawal of the medical fluid from the vial and compensating for such withdrawal of the medical fluid from the vial.

21. The system of claim 20, further comprising a medical connector interface in fluid communication with the extractor channel.

22. The system of claim 21, wherein the medical connector interface is configured to interface with a syringe that has no exposed needle.

23. The system of claim 20, further comprising a barrier configured to separate the initial volume of regulating fluid from ambient air to maintain the initial volume of regulating fluid in a sterile condition until use.

24. A method of manufacturing a system configured to couple with a vial containing a medical fluid, the method comprising:

forming a distal extractor aperture configured to permit withdrawal of the medical fluid from the vial as a result of the system being coupled to the vial;

forming a regulator channel;

forming a reservoir configured to be placed in fluid communication with the regulator channel, the reservoir containing an initial volume of a regulating fluid, the reservoir configured to decrease in volume as a result of the medical fluid being withdrawn from the vial via the extractor channel; and

forming at least one piercing member having a distal regulator aperture leading to the regulator channel, wherein the at least one piercing member is configured to pierce a septum of the vial and thereby be placed in fluid communication with an interior of the vial as a result of the system being coupled with the vial;

wherein the initial volume of regulating fluid comprises sterilized gas configured to remain sterile up through coupling the system with the vial; and

wherein the reservoir is configured to supply at least some of the initial volume of regulating fluid to the vial via the regulator channel, thereby facilitating withdrawal of the medical fluid from the vial and compensating for such withdrawal of the medical fluid from the vial.

25. The method of claim 24, wherein the extractor channel is in fluid communication with a medical connector interface configured to interface with a syringe that has no exposed needle.

26. The system of claim 24, wherein the reservoir is configured to supply at least some of the initial volume of regulating fluid to the vial as pressure within the vial drops.